Navina™ Classic System Small 69007 (REF 6900740)Recalls & reported problems
Wellspect AB · Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387026589), received between May 21, 2026 and May 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Free or Unrestricted Flow1
Patient problems
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Free or Unrestricted Flow
A COMPLAINT WAS RECEIVED INVOLVING A NAVINA CLASSIC IRRIGATION SYSTEM CONTROL UNIT. THE USER REPORTED THAT UPON REPLACING THE PUMP AND TUBING SET, IRRIGATION FLUID FLOWED THROUGH THE SYSTEM WITHOUT MANUAL PUMPING WHEN THE WATER CONTROL SWITCH WAS IN THE "ON" POSITION. THE REPORTED FLOW RATE WAS SIGNIFICANTLY HIGHER THAN EXPECTED, WITH APPROXIMATELY 300 ML OF IRRIGATION FLUID INFUSED IN LESS THAN ONE MINUTE, COMPARED TO THE TYPICAL INFUSION TIME OF 2-3 MINUTES. DURING USE OF THE AFFECTED CONTROL UNIT, THE PATIENT (PEDIATRIC USER WITH SPINA BIFIDA) EXPERIENCED EPISODES OF VOMITING DURING IRRIGATION, INCLUDING ONE INSTANCE OF EMESIS ON ONE DAY AND TWO INSTANCES ON ANOTHER DAY. NO MEDICAL TREATMENT WAS SOUGHT, AND NO HOSPITALIZATION OR SERIOUS INJURY WAS REPORTED. THE USER DISCONTINUED USE OF THE NEW CONTROL UNIT AFTER THREE DAYS AND RESUMED USE OF A PREVIOUS CONTROL UNIT WITH THE SAME TUBING, AFTER WHICH THE ISSUE WAS NOT OBSERVED.
Patient problems: Vomiting
MAUDE report 25239447 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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